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04.29.21 -- COVID-19's Impact On Outsourced Small Molecule Manufacturing


04.29.21 COVID-19 s Impact On Outsourced Small Molecule Manufacturing
 
 
Catching up to the paradigm shift in optimizing, scaling up, and manufacturing plasmids is crucial for clinical to commercial program success for gene therapies and vaccines. With an increased demand for plasmids for targeted gene therapeutic delivery, partnering with a CDMO equipped with the capacity, expertise, and equipment for plasmid DNA production is critical to ensuring a stable therapeutic supply. Join Aji Bio-Pharma to learn about methodologies to ensure effective production and increase the likelihood of market success.
Featured Editorial
By ISR Reports
In Q4 2020, ISR surveyed 249 sponsors who outsource small molecule manufacturing to learn if their company experienced outsourced manufacturing complications as a result of the COVID-19 pandemic. Small molecule drug substance outsourcers were slightly more likely to report complications t ....

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Renzo DiCarlo of BioPharma Services Inc. Presents COVID-19 Vaccine Strategies to Canadian Parliament


Press release content from Business Wire. The AP news staff was not involved in its creation.
Renzo DiCarlo of BioPharma Services Inc. Presents COVID-19 Vaccine Strategies to Canadian Parliament
April 27, 2021 GMT
TORONTO (BUSINESS WIRE) Apr 27, 2021
Renzo DiCarlo, CEO of BioPharma Services Inc. was proud to be invited to appear as a witness before the House of Commons’ Standing Committee on International Trade, in view of its study entitled
.
As a London School of Economics (LSE) alumnus in stakeholder theory research with 25 years of experience in Pharmaceutical GMP and Medical research, Renzo DiCarlo is uniquely qualified to comment on Canada’s future strategy to manage COVID-19, vaccination cycles and the Variants of Concern (VOC) that are now appearing. ....

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Fairmarkit Helps PCI Pharma Services Automate Sourcing of MRO Spend


Fairmarkit Helps PCI Pharma Services Automate Sourcing of MRO Spend
Utilizing Fairmarkit, PCI has been able to manage over 800 MRO sourcing events across their two largest locations in the United States with no need to onboard additional headcount.
April 20, 2021
Getty Images
PCI Pharma Services is a leading pharmaceutical and biopharmaceutical global outsourcing solutions provider with rapid growth through M&A. It provides a broad range of integrated pharmaceutical supply chain solutions from the earliest stages of drug development through to commercial launch, acting as the clients’ bridge between life-changing therapies and patients.
The challenge
Acquiring three companies in two years led PCI Pharma Services to grow rapidly and soon have multiple teams across multiple locations globally. This growth made visibility into spend and consistency in processes difficult. Like many other companies, they were not able to focus on managing the bott ....

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04.20.21 -- FDA Inspections: Are Changes On The Horizon?


04.20.21 FDA Inspections: Are Changes On The Horizon?
 
 
To get the most out of data, you must ensure they are findable, accessible, interoperable, and reusable F.A.I.R. for short. Organizations simply don’t have the infrastructure in place to be able to capture data with context and then store them so that they can be searched and accessed with ease. We’ll explore how you can change that using the F.A.I.R. principles, which have been recognized as standards to enable for that potential to be realized.
Featured Editorial
By Kalah Auchincloss, Greenleaf Health, Inc.
A year into the pandemic, the FDA is still conducting only limited inspections in the U.S. and evidence has emerged of a significant inspection backlog that could compromise the safety and quality of the U.S. drug supply. Kalah Auchincloss of Greenleaf Health provides a brief timeline of inspection-related events over the last year, discusses the impac ....

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